Thermoacoustic-enhanced ultrasound to estimate liver fat
Official title: Thermoacoustic Method for Estimating Liver Fat Fraction - Pilot Study I
Run by Endra Lifesciences · NCT07321925 · Data updated 2026-11-12
This study tests whether a thermoacoustic-enhanced ultrasound device can accurately measure liver fat in adults with fatty liver disease by comparing results to MRI-PDFF.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 49 (estimated) |
| Sponsor | Endra Lifesciences Industry-sponsored |
| Locations | 1 site (Ann Arbor, Michigan) |
| Status | Recruiting |
| Started | August 15, 2025 |
| Main results expected | October 30, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | January 7, 2026 |
| Trial ID | NCT07321925 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with suspected or known MASLD/MASH or nonalcoholic fatty liver who can tolerate both ultrasound and MRI and meet the listed inclusion/exclusion criteria are eligible.
✕Probably not a fit
People who cannot have MRI (for example due to metal or electronic implants, pregnancy, or other excluded liver diseases) or whose liver is not accessible by ultrasound would not benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will enroll up to 80 adults with suspected or known MASLD/MASH or fatty liver disease. Each participant will receive a thermoacoustic-enhanced ultrasound scan followed by an abdominal MRI with PDFF sequences as the gold-standard comparison. The study will compare the device's fat fraction results to MRI-PDFF and calculate correlation, accuracy, sensitivity, specificity, PPV, NPV, and AUC of the ROC curve. Data will determine how well the noninvasive ultrasound approach matches quantitative MRI measurements.
Why it matters
Potential benefit: If successful, the device could provide a quicker, more accessible way to measure liver fat without needing MRI.
How similar studies have gone: MRI-PDFF is the established gold standard and other ultrasound-based fat measures have shown mixed accuracy, while thermoacoustic-enhanced ultrasound is a relatively novel approach with limited published validation to date.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Study participants are 18 or older. * Able to understand, read, and provide written informed consent in English. * Able to tolerate both ultrasound and MRI examinations. * Able to lie flat, or on their side, for 20 minutes and pause breathing for up to 10 seconds. Exclusion Criteria: * Metal or electronic implants, including, but not limited to: pacemakers, metal clips, drug delivery pumps, hip implants, and neural stimulation devices, contraindicates for MRI. * Known pregnancy the day of consent or becoming pregnant during study participation based on start date of last menstrual period). * Liver diseases other than MASLD/MASH/fibrosis including, but not limited to: * Cirrhosis * Hepatocellular carcinoma * Ascites * Patients with broken, or injured skin, in the right upper abdominal quadrant. * Body habitus, or anatomical variation, where the liver capsule is not accessible with ultrasound through the patient's right intercostal imaging window used in conventional ultrasound liver imaging. * BMI greater than 50 kg/m2 * Patients with subcutaneous fat at measurement location less than or equal to 6mm. * Patients with a missing liver lobe. * Patients with peri-hepatic fat in the measurement location. * Patients with focal liver lesions or anatomical structures in the measurement location, as detected by ultrasound.
Where it's running
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ENDRA Life Sciences
Ann Arbor, Michigan, United States Recruiting
Study contacts
- Study coordinator: Ziad Rouag
- Email: zrouag@endrainc.com
- Phone: 415-531-4647
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.